NCT03631602Unknown2 期
Posaconazole Oral Suspension and Itraconazole Oral Solution in Preventing Invasive Fungal Disease (IFD) in Patients With Hematopoietic Stem Cell Transplantation
Fujian Medical University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年10月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Incidence of breakthrough IFD
研究概览
简要总结
Invasive Fungal Disease (IFD) after haematopoietic stem cell transplantation (HSCT) remain a clinical challenge.The studay aims to compare the efficacy and safety of posaconazole oral suspension vs itraconazole oral solution in preventing IFD post-HSCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent Aged ≥13 years Patients undergoing hematopoietic stem cell transplantation. Cardiac: Left ventricular ejection fraction ≥ 50% Adequate renal and hepatic function Performance status: Karnofsky ≥ 70%
排除标准
- •Pregnant or lactating females Any co-morbidity precluding the administration ofposaconazole or itraconazole
研究组 & 干预措施
Arm 1
Experimental
posaconazole oral suspension
干预措施: antifungal prophylaxis (Drug)
Arm 2
Active Comparator
itraconazole oral solution
干预措施: antifungal prophylaxis (Drug)
结局指标
主要结局
Incidence of breakthrough IFD
时间窗: 1 year
次要结局
- Overall survival(1 year)
- treatment-related mortality(1 year)
研究者
Ting YANG
Prof.M.D.Ph.D
Fujian Medical University
研究点 (1)
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